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A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Patients with histologically or cytologically confirmed stage IIIB or stage IV
advanced primary non-small cell lung cancinoma

- Age 18 years or older

Exclusion Criteria:

- Received investigational (not yet approved by a regulatory authority) or
non-investigational agent to treat Lung Cancer

- Received radiation therapy within 4 weeks before randomization

- Major surgery within 4 weeks before randomization

- Minor surgery within 2 weeks before randomizaiton

- Systemic steroids within 1 week before randomization

- Any grade 2 or greater neuropathy

- History of severe (Grade 4) hypersensitivity reaction to products containing
Cremophor EL (cyclosporine, teniposide)

- History of any infection requiring hospitalization or antibiotics within 2 weeks
before randomization

- Known brain or spinal cord metastases

- History of other cancers within 5 years before randomization

- Known HIV, hepatitis-B or hepatitis-C infection

- Pregnant or breast-feeding women

- Previously treated with Mapatumumab

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response and Progression free survival

Outcome Time Frame:

6 cycles, or until disease progression or unacceptable toxicity develops

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HGS1012-C1072

NCT ID:

NCT00583830

Start Date:

January 2007

Completion Date:

February 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
University of Colorado Health Sciences CenterDenver, Colorado  80262
Osceola Cancer CenterKissimmee, Florida  34741
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201
Lagrange Oncology AssociatesLa Grange, Illinois  60525
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
Fairfax-Northern Virginia Hematology Oncology, PCFairfax, Virginia  22031
Orchard Research, LLCSkokie, Illinois  60076
Chevy Chase Health CareChevy Chase, Maryland  20815
Medical University of South Carolina: Hollings Cancer CenterCharleston, South Carolina  29425
UT Health Science Center at San Antonio, Be Well CenterSan Antonio, Texas  78229